Objective Measures in Implantable Hearing Devices

NCT ID: NCT01780025

Last Updated: 2023-01-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 15 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2020-11-30

Brief Summary

The purpose of this study is to measure objectively the coupling from direct acoustic cochlear stimulation to the inner ear with a non-invasive technique of auditory evoked potentials.

Detailed Description

A new technique, called Direct Acoustic Cochlear Stimulation, has very recently been introduced to restore hearing in patients with severe hearing loss due to the immobility of a small ossicle in the middle ear, the stapes. A piston-like prosthesis, which is placed up into the inner ear, is connected to an implantable mechanical stimulator, named DACS. Unfortunately, as with other active middle ear implants, until now the correct function of this technique cannot be checked during the surgery, leading to a possibly variable outcome of hearing. In this project, the objective auditory evoked potentials, like Auditory Steady-State Response (ASSR), will be used to measure the efficacy of this method of inner ear stimulation. This highly innovative, non-invasive research will provide valuable insight in a new promising way of inner ear stimulation and may give a unique possibility to measure the correct connection from an implantable hearing device to the inner ear.

Conditions

Mixed Hearing Loss

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Mixed hearing loss

Auditory evoked potentials and audiometry

Intervention Type: BEHAVIORAL

Auditory evoked potentials

Intervention Type: BEHAVIORAL

Different protocols for audiometry and auditory evoked potentials

Interventions

Auditory evoked potentials and audiometry

Intervention Type: BEHAVIORAL

Auditory evoked potentials

Different protocols for audiometry and auditory evoked potentials

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• adults
• mixed hearing loss

Exclusion Criteria

• children

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fund for Scientific Research, Flanders, Belgium

OTHER

Sponsor Role: collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

UZ Leuven

Leuven, , Belgium

Countries

Belgium

Other Identifiers

S53530

Identifier Type: -

Identifier Source: org_study_id